A Phase II Study of Paclitaxel/Carboplatin Plus Bevacizumab/Erlotinib in the First Line Treatment of Patients With Carcinoma of Unknown Primary Site
All eligible patients will receive:
- Bevacizumab 15mg/kg IV infusion,Day 1
- Paclitaxel 175mg/m2, 1-3 hour IV infusion,Day 1
- Carboplatin AUC 6.0 IV Day 1
- Erlotinib 150 mg by mouth daily
The regimen will be repeated every 21 days for a total of 4 courses. Patients will be
initially evaluated for response after completing 2 courses (6 weeks) of treatment. Patients
with an objective tumor response or stable disease will continue treatment for another 2
courses. Patients will be re-evaluated after 4 courses and those with objective tumor
response or stable disease will stop chemotherapy with paclitaxel/carboplatin and continue
treatment with bevacizumab/erlotinib until tumor progression is documented for a maximum of
12 months. During treatment with bevacizumab/erlotinib response will be evaluated every 12
weeks.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Overall survival
18 months
No
John D. Hainsworth, MD
Principal Investigator
Sarah Cannon Research Institute
United States: Food and Drug Administration
SCRI UNKPRI 19
NCT00360360
July 2006
March 2009
Name | Location |
---|---|
Northeast Georgia Medical Center | Gainesville, Georgia 30501 |
Spartanburg Regional Medical Center | Spartanburg, South Carolina 29303 |
Baton Rouge General Medical Center | Baton Rouge, Louisiana 70821-2511 |
Integrated Community Oncology Network | Jacksonville Beach, Florida 32250 |
Tennessee Oncology, PLLC | Clarksville, Tennessee 37043 |
Oncology Hematology Care | Cincinnati, Ohio 45242 |
Oncology Hematology Associates of SW Indiana | Evansville, Indiana 47714 |
Graves-Gilbert Clinic | Bowling Green, Kentucky 42101 |
Chattanooga Oncology Hematology Associates | Chattanooga, Tennessee 37404 |